Oral Dydrogesterone as Luteal Phase Support in Natural Cycle FET

November 27, 2023 updated by: The University of Hong Kong

A Randomized Double Blind Controlled Comparison of Oral Dydrogesterone as Luteal Phase Support in Natural Cycle Frozen-thawed Embryo Transfer

This randomised double-blinded controlled trial aims to compare the live birth rate in natural FET cycles with and without oral dydrogesterone as luteal phase support. The hypothesis is that the use of oral dydrogesterone will increase the live birth rate of natural cycle FET.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Trial design:

Women undergoing FET in the Centre of Assisted Reproduction and Embryology, The University of Hong Kong-Queen Mary Hospital, will be recruited and will be randomized into one of the following two study groups:

Treatment group: Oral dydrogesterone 10mg tds will be given for two weeks from the next day of the LH surge or hCG induced ovulation.

Control group: Placebo will be given given for two weeks from the next day of the LH surge or hCG induced ovulation.

Treatment of subjects

Ovarian stimulation protocol:

All women received ovarian stimulation according to the standard protocol of the Centre. Egg collection is carried out 36 hours after the HCG trigger. One to two early cleaving embryos or blastocysts will be transferred and any excess good quality cleaving embryos or blastocyst will be frozen two to six days after egg collection.

FET cycle:

FET is carried out at least 2 month after the stimulated cycle if the patient fails to get pregnant in the stimulated IVF cycle. Frozen cleaving embryos or blastocysts after thawing are transferred in natural cycles for those women having regular ovulatory cycles. Women are monitored daily from 18 days before the expected date of he next period for pelvic ultrasound assessment of the size of the leading follicle and determination of serum oestradiol (E2) and LH concentrations until the LH surge, which is defined by the LH level being above 20 IU/L and more than double of the average of the LH levels over the past three days. HCG can also be given when the leading follicle reaches 17mm in diameter.

Women will be counseled by a designated research nurse who will explain the purpose of this study when they first attend the clinic for FET. On the day of the hCG trigger or one day after the LH surge, those who consent to join the study will be randomized into one of the two study arms specified in an opaque envelope according to a computer-generated randomization list prepared by a research nurse who is not involved in the present study. Oral dydrogesterone and placebo tablets have the same appearance and will be started one day after the hCG trigger or the LH surge for two weeks.

The transfer is performed on the third day after the LH surge or the fourth day after the hCG trigger for frozen cleaving embryos (on the sixth day after the LH surge or the seventh day after hCG trigger for frozen blastocysts). Again 1-2 cleaving embryos are replaced according to our standard protocol. A urine pregnancy test will be performed 16 days after the FET. In case of pregnancy, the outcome of pregnancy will be traced afterwards and used for analysis. Luteal phase support is not required in those who get pregnant.

Study Type

Interventional

Enrollment (Estimated)

716

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ernest HY Ng, MD
  • Phone Number: 852-28553400
  • Email: nghye@hku.hk

Study Locations

  • China
    • Hong Kong
      • Hong Kong, Hong Kong, China
        • Recruiting
        • Department of Obstetrics and Gynaecology
        • Contact:
          • Ernest HY NG, MD
          • Phone Number: 852-22553400
          • Email: nghye@hku.hk
        • Principal Investigator:
          • Ernest HY NG, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age of women <43 years at the time of stimulated IVF
  • Replacing early cleavage embryos or blastocysts after thawing

Exclusion Criteria:

  • Requiring hormonal replacement cycles
  • Use of donor oocytes or embryos
  • Undergoing preimplantation genetic testing
  • Presence of hydrosalpinx not corrected surgically prior to FET
  • Refusal to join the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dydrogesterone group
Oral dydrogesterone 10mg tds will be given for two weeks from the next day of the LH surge or hCG induced ovulation.
Drug: Dydrogesterone
Progesterone
Other Names:
  • Duphaston
Placebo Comparator: Placebo group
Placebo will be given given for two weeks from the next day of the LH surge or hCG induced ovulation.
Drug: Placebo
Placebo with appearance similar to Dydrogesterone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
live birth rate
Time Frame: 10 months after recruitment
the number of live birth beyond 22 weeks gestation per transfer cycle
10 months after recruitment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical pregnancy rate
Time Frame: 6 weeks of gestation after recruitment
the number of women with an intrauterine gestational sac at 5-6 weeks of gestation
6 weeks of gestation after recruitment
Ongoing pregnancy rate
Time Frame: 10 weeks of gestation after recruitment
the number of intrauterine pregnancies with fetal pulsation beyond 10 gestation per transfer cycle
10 weeks of gestation after recruitment
Pregnancy loss per number of transfer cycles
Time Frame: less than 22 weeks of gestation
Miscarriage
less than 22 weeks of gestation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Investigators

  • Principal Investigator: Ernest HY Ng, MD, The University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

November 30, 2025

Study Registration Dates

First Submitted

February 26, 2019

First Submitted That Met QC Criteria

February 28, 2019

First Posted (Actual)

March 1, 2019

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UW 18-594

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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